Role of the Microbiome in Graves' Orbitopathy (Indigo)
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|ClinicalTrials.gov Identifier: NCT02373995|
Recruitment Status : Unknown
Verified February 2015 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was: Not yet recruiting
First Posted : February 27, 2015
Last Update Posted : February 27, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Graves' Disease||Biological: LAB4||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Investigation of Novel Biomarkers and Definition of the Role of the Microbiome In Graves' Orbitopathy|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||December 2016|
Active Comparator: LAB4
In addition to conventional Anti Thyroid Drug (ATD), LAB4 probiotic preparation will be administered at the 2 cps x 2/die dosing with food for 6 months. It is key to properly store LAB4 at 8°C.
Additional treatment with the specific LAB4 probiotic preparation
Placebo Comparator: Placebo
In addition to conventional Anti Thyroid Drug (ATD) a LAB4 placebo preparation will be administered at the 2 cps x 2/die dosing with food for 6 months. It is key to properly store placebo at 8°C.
- Microbiome modification (beneficial modification of the gut microbioma relates to a reduction at the end of treatment of at least 5% of the Firmicutes:Bacteroides ratio and 30% of the anti-TSHr antibody titer and of total IgG and IgA concentrations) [ Time Frame: 6 months ]modification the microbiome in GD patients to reduce pathogenic species and enrich its commensal, symbiotic components. The proportion (%) of each species will be assessed and recorded.
- Improvement immunological status (antibody responses will be analyzed to identify if microbial or food derived antigens are involved in triggering disease or associated with GO progression) [ Time Frame: 6 months ]To decrease the anti-TSHr antibody titer and the concentration of IgG and IgA in patients with Graves' disease. The concentration of each parameter will be assessed in mg/dl and recorded.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Group A: Untreated Graves' hyperthyroidism (or within 4 weeks of initiating ATD treatment)
- definition hyperthyroidism: TSH decreased, FT4 and /or FT3 increased
- definition Graves': diffusely enlarged thyroid gland either by palpation or echograpy, and/or homogeneous thyroid uptake at scintigraphy, or positive TSHRAb
- first episode or recurrence of Graves' hyperthyroidism
- minimal or no eye signs, defined as lid retraction / lid lag but no other signs.
Planned treatment with antithyroid drugs either titration regimen or block-and-replace regimen for 18 months.
Group B. Untreated Graves' hyperthyroidism (or within 4 weeks of initiating ATD treatment) with overt signs of GO as defined by EUGOGO1
- Mild GO: patients whose features of GO have only a minor impact on daily life insufficient to justify immunosuppressive or surgical treatment. They usually have only one or more of the following: minor lid retraction (<2 mm), mild soft tissue involvement, exophthalmos <3 mm above normal for race and gender, transient or no diplopia, and corneal exposure responsive to lubricants)
- Moderate-to-severe GO: Patients without sight-threatening GO whose eye disease has sufficient impact on daily life to justify the risks of immunosuppression (if active) or surgical intervention (if inactive). Patients with moderate-to-severe GO usually have any one or more of the following: lid retraction R2 mm, moderate or severe soft tissue involvement, exophthalmos >3 mm above normal for race and gender, inconstant, or constant diplopia.
- Sight -threatening GO: Patients with dysthyroid optic neuropathy (DON) and/or corneal
- Previous or planned treatment with 131I or thyroidectomy (A&B); sight threatening GO requiring decompression (B); drugs interfering with the natural course of GO (A&B): steroids, immunosuppressants, thiazolidinediones, antibiotics / antifungals / antivirals (both topical and systemic for at least 4 weeks prior to recruitment to the study); acute diarrhea illness (gastroenteritis for at least 4 weeks prior to recruitment to the study); Drugs interfering with thyroid function (A&B): amiodarone, lithium, iodine supplements; Drug or alcohol abuse (A&B); no informed consent (A&B); Age less than 18 (A&B); Pregnancy (A&B).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373995
|Contact: Mario Salvi, MDemail@example.com|
|Contact: Giuseppe Colucci, MDfirstname.lastname@example.org|
|Fondazione Ca' Granda Ospedale Maggiore Policlinico|
|Milan, Italy, 20122|
|Principal Investigator:||Mario Salvi, MD||IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico Milano|
|Responsible Party:||Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico|
|Other Study ID Numbers:||
|First Posted:||February 27, 2015 Key Record Dates|
|Last Update Posted:||February 27, 2015|
|Last Verified:||February 2015|
Endocrine System Diseases
Immune System Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn